Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:48 AM
Study NCT ID:
NCT07450794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty
Sponsor:
Istinye University
Organization:
Study Overview
Official Title:
Association Between Weight-Based Equivalent of Fixed 1 g Tranexamic Acid and Intraoperative Remifentanil Titration Frequency and Anesthesiologist Workload in Septorhinoplasty: A Prospective Observational Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective observational cohort study aims to investigate whether the weight-based equivalent (mg/kg) of a fixed 1 g dose of tranexamic acid administered during septorhinoplasty is associated with intraoperative remifentanil titration frequency and perceived anesthesiologist workload. Although tranexamic acid is routinely given as a fixed dose, its mg/kg equivalent varies according to patient weight and may influence hemodynamic management during controlled hypotension. The primary outcome is the total number of remifentanil infusion rate adjustments during surgery. Secondary outcomes include total remifentanil consumption and postoperative anesthesiologist workload assessed using the NASA Task Load Index (NASA-TLX).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: